Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

Not Applicable

• Conditions: Heart Failure, Systolic
• Interventions: Other: MRI

• Registration Number: NCT03183011
• Lead Sponsor: Kenneth Bilchick, MD

Brief Summary

This study is evaluating how MRI after CRT can provide key insights regarding LV function, structure, and mechanics resulting from CRT in patients with or without LV scar and inform optimal pacing strategies. The expected accurate and reproducible response assessment with cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and the insights from the post-CRT MRI promise to improve implementation of CRT.

Detailed Description

We are performing a study of 40 patients with current accepted indications for CRT and no MRI contraindications. These patients will have a pre-CRT MRI and another post-CRT MRI 6 months after the CRT procedure. Echocardiography, cardiopulmonary exercise testing, symptom assessment, and laboratory testing are also performed before and after CRT. Modifications to the post-CRT MRI protocol include the use of gradient echo cine imaging rather than steady state free precession imaging, application of wideband imaging to the LGE acquisitions, and strain imaging with cine Displacement Encoding with Stimulated Echoes (DENSE) tailored for device patients.

Study Timeline

• Study Start: 2016-11-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-07
• Last Update Submitted: 2017-06-08
• Study First Posted: 2017-06-09
• Last Update Posted: 2017-06-12
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Chronic systolic HF
• LVEF 35% or less
• Guideline-based class I or IIa indication for CRT
• 25 and 85 years old
• Predominantly in sinus rhythm
• GFR ≥ 40 ml/min/1.73m2* *Contrast will not be given for the 6-month follow-up scan if the GFR falls to < 40 ml/min/1.73m2.

Exclusion Criteria

• Inability to provide informed consent
• Pregnancy
• Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
• Preexisting pacemaker or defibrillator prior to enrollment
• Cerebral aneurysm clips; 6) cochlear implants
• Other metallic implants (prior to enrollment) known to be contraindications to MRI
• Severe claustrophobia
• Acute kidney injury
• Acute renal failure or chronic kidney disease with GFR < 40 cc/min
• Liver transplant
• Gadolinium allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-CRT MRI	MRI	This study has a single arm. Enrolled patients will follow the protocol as described, including evaluation with MRI, echocardiography, and cardiopulmonary exercise testing.

Primary Outcome Measures

Name	Time	Method
CRT Response	1 year	CRT Response

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States